Kornimate/medical-research-clean huggingface dataset:
study on the utilization of cabozantinib in adult patients with advanced or metastatic renal cell carcinoma (rcc) in 2nd line treatment following prior vascular endothelial growth factor (vegf)-targeted therapy under real-real life clinical setting in france.

Conditions: Renal Cell Carcinoma

Summary: the purpose of the protocol is to assess the overall survival (os) at 1 year in patients after cabozantinib initiation.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 age at the time of cabozantinib initiation * pathologically confirmed diagnosis of renal cell carcinoma (clear cell or non-clear cell) cancer considered as advanced or metastatic at the time of cabozantinib initiation * intention to be treated with cabozantinib tablets according to the current local summary of product characteristics (smpc) (france) * initiating cabozantinib as a second line of treatment (baseline visit must be performed before cabozantinib first intake) exclusion criteria: * he/she is already included in an interventional trial with an investigational product at the same time.

Keywords: renal cell carcinoma (clear cell or non-clear cell)
computerised testing of cognitive response to cerebrospinal fluid shunting in idiopathic normal pressure hydrocephalus

Conditions: Normal Pressure Hydrocephalus

Summary: a novel computerised neuropsychological test battery for normal pressure hydrocephalus (nph) has been developed. the aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for nph. results from the battery indicate good reliability and validity for the computerized tests results from the computerised battery seems promising. however, ability for the battery to detect cognitive improvements after a shunt operation remains to be tested. study objectives 1. improvement after shunt. the aim of this study is to evaluate the effects of shunting on neuropsychological performance in nph patients, using a computerized battery. 2. feasibility. the ability to complete the test battery by the intended patient group will be tested. 3. baseline profile. baseline scores for nph-patients will be compared to scores of healthy individuals (from previous study).


Eligibility criteria:
inclusion criteria: * older than 60 years of age "probable inph" according to the nih guidelines planned shunt surgery based on a diagnosis of inph. exclusion criteria: * known cause for hydrocephalus (i.e., secondary nph). medical condition preventing cognitive testing (e.g. deafness, blindness). patients not considered for shunt operation.

Keywords: normal pressure hydrocephalus neuropsychological test assessment of cognitive disorders/dementia neuropsychological assessment
effectiveness of the application of percutaneous electrolysis on muscular scar tissue.

Conditions: Muscle Injury; Fibrosis

Summary: objective: determine the effectiveness of an intervention that consists of the application of percutaneous electrolysis in different doses compared to the application of a simulated intervention in adults who present a muscle tear in the internal gastrocnemius. material and methods: around fifty adults with muscle tears in the medial gastrocnemius will be included in the following study. the first group will be treated with high-intensity percutaneous electrolysis (3 ma), the second group will be treated with low-intensity percutaneous electrolysis (0.3 ma), and the third group will receive a sham intervention. myofascial pain, level of kinesiophobia, range of ankle dorsiflexion with full knee extension, and triceps surae muscle fatigue will be evaluated both before and after treatment. applicability of the expected results: the results of this study are intended to help provide information about the effects of electrolysis on muscle tears, thus improving their management. likewise, this work can contribute to the knowledge of the use of percutaneous electrolysis since it applies two protocols with different intensity and application time. in this way, it will provide information on the treatment, management and prognosis of muscle injuries addressed through invasive physiotherapy and more specifically, percutaneous electrolysis.


Eligibility criteria:
inclusion criteria: * muscle injury in the medial gastrocnemius * pain in the area of injury * informed of the purpose, risks and benefits of this study and written consent to participate in the trial. * available for follow-up. exclusion criteria: * active rehabilitation for another musculoskeletal pathology. * belenophobia * immunosuppression. * uncontrolled metabolic diseases.

Keywords: tennis leg gastrocnemious injury fibrosis percutaneous electrolysis
safety and efficacy of rm-004 cells for hemoglobin h-constant spring disease

Conditions: Alpha Thalassemia Hemoglobin H Constant Spring; Hemoglobinopathies; Hereditary Diseases

Summary: the purpose of this study is to evaluate the safety and efficacy of rm-004 for hemoglobin h-constant spring disease.

this is a non-randomized, one-arm, open label study to evaluate the safety and efficacy of rm-004 for autologous hematopoietic stem cell transplantation (hsct) for the treatment of hemoglobin h-constant spring disease. five subjects aged from 12 to 35 years will be recruited in this study.

Eligibility criteria:
inclusion criteria: 1. subjects voluntarily sign informed consent by themselves or their legal guardians and complete the study procedures, follow-up examination and treatment. 2. at the time of screening, subjects should be aged from 12 to 35 years old, regardless of gender. 3. history of at least 100 ml/kilograms (kg)/year of packed red blood cells (prbc) transfusions in the prior 2 years before screening. 4. subjects diagnosed with hemoglobin h-constant spring disease (--/ααcs) with hba2 c.427t\>c mutation. exclusion criteria: 1. subject who has an available hla-matched/well-matched hsct donor for allogeneic hematopoietic stem cell transplantation (hsct). 2. prior hsct or gene therapy. 3. history of severe hemorrhagic disease. 4. clinically significant active bacterial, viral, fungal or parasitic infections per investigator's judgement at the time of screening.

Keywords: rm-004 hemoglobin h-constant spring disease alpha-thalassemia gene therapy cbe
be of euthyrox® tablets (merck nantong versus merck darmstadt sites)

Conditions: Healthy

Summary: the purpose of this study is to demonstrate bioequivalence (be) between euthyrox® tablets manufactured at merck nantong (test euthyrox) versus the tablets manufactured at merck darmstadt (reference euthyrox).


Eligibility criteria:
inclusion criteria: * participants have a body weight within 45 to 75 kilogram (kg) for females and 55 to 85 kg for males and body mass index (bmi) within the range 19.0 to 26.0 kilograms per meter square (kg/m\^2) * non-smoker for at least 3 months * contraceptive use by males or females will be consistent with any local regulations on contraception methods for those participating in clinical studies * capable of giving signed informed consent * total and free thyroxine (t4), total and free triiodothyronine (t3) and thyroid-stimulating hormone (tsh) must be within normal ranges at screening * ability to understand the purposes and risks of the study * other protocol defined inclusion criteria could apply exclusion criteria: * participants with history or presence of tumors of the pituitary gland or hypothalamus, thyroid or adrenal gland dysfunction or cardiac disease * participants with a concurrent medical condition known to interfere with the absorption or metabolism of thyroid hormones * history or presence of relevant liver diseases or hepatic dysfunction. participants with gall bladder removal * participants taking medications known to affect thyroid hormone metabolism, for example, oral contraceptives, hormonal implants, parenteral hormones, anabolic steroids, androgens, etcetera * use of any investigational device within 60 days prior to first dose administration * pregnant or breastfeeding a child * participant has smoked within the 3 months prior to screening * high fiber consumption within 24 hours before dosing in each period * participants with positive results from serology examination for syphilis, hepatitis b surface antigen, hepatitis c virus or human immunodeficiency virus * participants with any clinically relevant abnormality in the safety laboratory parameters * participants with positive test for drugs of abuse (including alcohol) at screening and on day -1 of each period (urine) * other protocol defined exclusion criteria could apply

Keywords: euthyrox® bioequivalence thyroid-stimulating hormone thyroxine
proof of concept open label, clinical trial to evaluate the safety and efficacy of the "fitt" device in diabetic foot ulcers patients

Conditions: Diabetic Foot Ulcer

Summary: the trio fitt device is designed to improve the symptoms of chronic diabetic ulcers. the mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. the treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.


Eligibility criteria:
inclusion criteria: * males and females 18-80 years old * chronic diabetes mellitus type 1 and type 2 diagnosed at least 3 years before the screening * have a single non-infected diabetic hard-to-heal wound (ulcers/foot ulcers) ≤ 0.8-40 cm2 wound area at start of treatment, for period of at least for 3 months. * wagner classification stage 1 or 2 or post-debridement stage 3. * at least moderate blood perfusion into the affected limb as defined by ankle brachial index (abi) ≥0.65 * stable diabetic drugs 4 weeks before screening * be available for the entire study period, and be able and willing to adhere to protocol requirements * provide written informed consent prior to admission into the study exclusion criteria: * have a glycosylated hemoglobin (hba1c) \> 10.5% * have more than one wound * have a body mass index (bmi) \> 40 kg/m2 * have visible bone exposure at wound site * anemia (hemoglobin \ 11,000/μl or platelets count \ 3 times upper normal lab values or creatinine \> 3 mg/dl; any indication of malnourishment (albumin \ 2 or any other clinically significant blood and urinalysis tests per the physician's discretion * patients with unstable hypertension * have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except diabetes type 1 or 2 or during screening period * females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test * participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study * patients with active gangrenous foot ulcers * active osteomyelitis (have any signs of infection in the wound (which could be linked to raised body temperature), abscess, cellulitis, necrosis, erythema, mild drainage or known osteomyelitis) * patients with uncontrolled hyperthyroidism * patients with history of collagen diseases * patients with known allergy to ozone * anxiety, depression, history of mental illness or patient under guardian * any medical condition for which the investigator deems the subject unable to participate in the study
effect of administering intravenous magnesium sulfate on fetal cardiotocography and neonatal outcome in preeclamptic patients

Conditions: Preeclampsia

Summary: admission ctg for 20 minutes settings on a ctg machine was standardised to enable a consistent approach of interpretation of traces. paper speed of 3cm per minute will be adopted. maternal heart rate was recorded and noted on ctg. following birth date, time and mode of delivery will be labelled on ctg. magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows: * loading dose: 4-6 gm of magnesium sulphate diluted in 100 ml of iv fluid administered over 15-20 min. * maintenance dose: 2 gm/hr in 100 ml of iv infusion to be continued for 24 hours after delivery. another 20 minutes ctg strip will be performed 20 minutes after administration of iv loading mgso4, 7h2o and thus ensuring that mgso4 has reached peak serum levels

admission ctg: admission ctg will be performed for 20 minutes i-settings: 1. settings on a ctg machine will be standardised to enable a consistent approach of interpretation of traces. 2. paper speed of 3cm per minute will be adopted. 3. ctgs will be labelled with mother's name, hospital number. 4. date and time settings on machines will be labelled at commencement of tracing. 5. maternal heart rate will be recorded and noted on ctg. 6. following birth date, time and mode of delivery will be labelled on ctg. magnesium sulphate hepatahydrate administration: magnesium sulphate will be administered by continuous intravenous infusion according to our hospital protocol as follows: * loading dose: 4-6 gm of magnesium sulphate diluted in 100 ml of iv fluid administered over 15-20 min. * maintenance dose: 2 gm/hr in 100 ml of iv infusion to be continued for 24 hours after delivery. * magnesium toxicity was monitored by hourly assessment of: 1. patellar reflexes should be present. 2. respiratory rate not \< 16/min. 3. urine output not \< 100ml / hr. another 20 minutes ctg strip will be performed 20 minutes after administration of iv loading mgso4, 7h2o and thus ensuring that mgso4 has reached peak serum levels

Eligibility criteria:
inclusion criteria: 1. pregnant women in the third trimester. 2. severely preeclamptic patients. 3. singleton pregnancy. 4. patients with normal admission ctg exclusion criteria: 1. evidence of fetal anomalies on scan. 2. concomitant maternal morbidities as diabetes, cardiac disease. 3. patients contraindicated to take mgso4 e.g.: advanced renal disease. 4. abnormal admission ctg. 5. morbid obesity.

Keywords: preeclampsia mgso4
treatment of pain associated with lumbosacral radiculopathy in adults

Conditions: Lumbosacral Radiculopathy

Summary: this study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.


Eligibility criteria:
main inclusion criteria: 1. be between 18 and 70 years of age (inclusive) at time the informed consent form (icf) is signed. 2. diagnosis of unilateral radicular leg pain. 3. women of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to procedure and commit to adequate birth control during the the study. 4. understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study. 5. agrees to follow study-specific medication requirements. 6. be able to read, write, understand, and complete study-related tasks, and adequately communicate in english. 7. subject must have failed at least one conservative therapy in two different categories. main exclusion criteria: 1. medical condition or radiographic evidence that, in the investigator's opinion, could adversely impact study outcomes. 2. received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to screening. 3. female subjects who are pregnant or breastfeeding. 4. history of lumbar surgery.
use of high cost monitoring during letrozole ovulation induction

Conditions: Infertility

Summary: the purpose of this study is to investigate monitoring methods during ovulation induction cycles with letrozole and their effect on pregnancy rates. monitoring ovulation induction cycles with letrozole can be done with a variety of methods, the two most commonly utilized are home-based urinary lh kits (or ovulation predictor kits) and office-based midcycle follicular ultrasound. letrozole coupled with follicular monitoring by ultrasound may add extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).

the study will be a randomized controlled trial of adult women with primary and secondary infertility seen at the university of michigan health system undergoing ovulation induction (oi) with letrozole as part of their standard clinical care. patients who are undergoing oi with letrozole as per standard clinical care will be randomized to urinary luteinizing hormone (lh) ovulation predictor kit use versus mid-cycle ultrasound with administration of hcg when appropriate for timing of intercourse or intrauterine insemination. patients who have been prescribed letrozole as per routine clinical care will be approached to determine willingness to participate in this study. study period involves up to three ovulation induction cycles or until pregnancy occurs.

Eligibility criteria:
inclusion criteria: * women ages 21-39 undergoing letrozole ovulation induction (as part of routine clinical care) at a single academic-infertility center. * normal uterus and evidence of at least tubal patency on one side (as assessed by saline-infusion sonography or hysterosalpingogram per clinical care). exclusion criteria: * current pregnancy * nursing mothers * prior hypersensitivity to hcg preparations * primary ovarian failure or menopausal levels of fsh (\>12 miu/ml) * patients with abnormal uterine bleeding of undetermined origin or ovarian cyst of undetermined origin, sex-hormone dependent tumors, documented bilateral tubal obstruction, uncorrected uterine anomalies, * previous letrozole or gonadotropin use and/or previous treatment with in vitro fertilization * other uncorrected medical condition that would be a contraindication to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion, thyroid or adrenal disease).

Keywords: letrozole ovulation monitoring pregnancy rate
systematic pelvic lymphadenectomy versus no lymphadenectomy in clinical stage i-ii endometrial cancer

Conditions: Endometrial Cancer

Summary: the purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (dfs) and overall survival (os) in patients with preoperatively supposed stage i-ii endometrial cancer


Eligibility criteria:
inclusion criteria: * histologically proven endometrioid or adenosquamous endometrial carcinoma. * patients having myometrial invasion * age =/\< 75 years * informed consent. exclusion criteria: * serous papillary and clear cell tumors. * karnofsky index \< 80 or severe diseases contraindicating surgery * concomitant neoplasia (basalioma cutis excluded) * distant metastasis or abdominal metastasis detected intraoperatively. * absence of myometrial invasion at frozen section.

Keywords: histologically proved endometrial carcinoma preoperatively supposed stage i-ii
feasibility of exercise and spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of the study is to examine the impact of a community-based exercise intervention (cbei) for persons with spinal cord injury (pwsci) on physiological and psychological well-being and identify barriers and facilitators to implementation.

people with spinal cord injury (pwsci) are at a greater risk for major health conditions and poorer health outcomes than the population without spinal cord injury. for pwsci, habitual exercise is critical for both physiological and psychological well-being. prior research indicates that exercise programs conducted in a controlled setting have positive effects on the physical and psychosocial fitness of pwsci, but the efficacy and feasibility of these programs are not well understood in community-based settings. the proposed project aims to examine potential health benefits in response to the intervention and identify the barriers and facilitators to successful implementation of a cbei in pwsci. the long-term goal of this research is to improve health outcomes of pwsci by identifying strategies to promote health and support exercise in the community. the project research aims are to: 1. estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a cbei compared to an education-only group. 2. identify barriers, facilitators, and reasons for positive determinants for pwsci to exercise in a community-based setting. a single-blind pilot rct will be conducted. forty individuals with sci will be recruited. each participant will be randomized into either a 12-week cbei (n=20) or an education control group (n=20). participants' cardiorespiratory fitness, body composition, metabolic blood chemistries and strength will be assessed pre- (t1) and post- (t2) intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of sci * 18 years or older * have written physician approval to participate in the study * ability to use upper extremities to exercise * participate in \< 60 minutes of moderate-intensity exercise per week in the last month * understand english at a sixth-grade level or higher * be able to follow multi-step instructions * independently provide informed consent * willing to participate in three assessments and 36 intervention sessions exclusion criteria: * enrollment in a structured exercise program in the past six months. * have had cardiovascular complications within the past year * currently receive medical treatment for an acute upper extremity injury * have a stage iv pressure injury * have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.

Keywords: occupational therapy exercise
measurement of outcome of surgical treatment in patients with acromegaly

Conditions: Acromegaly

Summary: objectives: i. compare growth hormone (gh) levels at baseline and after glucose suppression measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric assay (irma) in patients with acromegaly and normal volunteers. ii. measure the levels of igf-i and its binding protein, igfbp-3, in these cohorts. iii. determine any correlation between levels of igf-i and igfbp-3 and gh suppressibility as assessed by sensitive irma. iv. determine if patients who demonstrate biochemical features of mild gh excess are at risk for progression to active disease.

protocol outline: blood samples are collected and assessed for growth hormone and igf-i by polyclonal radioimmunoassay (ria) and immunoradiometric assay (irma). growth hormone is measured at baseline and 60, 90, and 120 minutes after a 100 g glucose drink. serum glucose is measured at baseline and at 2 hours post dextrose administration by the glucose hexokinase method. clinical scores are determined for headache, perspiration, fatigue, joint pain, and acne. exams and tests may be repeated every 6 months for 2 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of acromegaly and treated with transsphenoidal surgery biochemically and histologically confirmed growth hormone secreting tumor or healthy volunteers --prior/concurrent therapy-- surgery: * see disease characteristics * greater than 6 months since prior surgery other: at least 1 month since prior bromocriptine or octreotide --patient characteristics-- performance status: ambulatory hepatic: no active hepatic disease renal: no active renal disease other: * no diabetes mellitus * no glucose intolerance * hypopituitarism allowed if on stable doses of replacement therapy

Keywords: acromegaly endocrine disorders rare disease